FDA Clears AviClear® as a Long-Term Treatment for Mild to Severe Acne

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AviClear by Cutera® Makes history with another first on the market proven safe and effective on all skin types with long-lasting results

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BRISBANE, Calif. – CUTERA, Inc. announced. (Nasdaq: CUTR), the leading global manufacturer of cosmetic and dermatological solutions, today announced new US Food and Drug Administration approval of AviClear as a company. Long term treatment For the treatment of mild to severe inflammatory acne. This is the first acne treatment that claims long-term efficacy for mild, moderate, and severe acne.

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AviClear initially received FDA clearance in March 2022 after an extensive clinical trial. Now, after months of evaluating clinical data, the FDA has also recognized AviClear as a proven, clinically effective treatment for long-term acne. AviClear selectively targets and suppresses sebaceous glands, eliminating acne at the source, offering a permanent, prescription-free option for patients and providers.

Those of us who have used AviClear on our patients since initial FDA authorization have recognized that treatment results gradually improve over time. Emmy M. Graber, MD, MBAFounder of the Dermatology Institute in Boston and a world-renowned acne expert. “I am pleased that these long-term results have now been recognized by the FDA, giving patients and dermatology providers greater confidence in the effectiveness and longevity of AviClear results.”

As the first 1726nm laser to market, AviClear continues to challenge the status quo in the acne landscape. In three 30-minute treatment sessions, 90% of patients saw a significant improvement in their acne six months after the third session.1 According to 12-month clinical data, improvement increases to 92%2which confirms the long-term efficacy of acne removal and skin quality over time.

AviClear’s success is a testament to Cutera’s ingenuity and innovation as a leading force in outcome-based technology,” said Sheila Hopkins, Interim CEO of Cutera. “Over the course of Cutera’s 25-year history, we have continued to develop devices that provide clinicians and their patients with great treatment options, and AviClear is a great example of our game-changing technologies.”

Interested providers and patients are encouraged to visit www.aviclear.com for more information.

About Cutera, Inc.

Cutera, based in Brisbane, California is a leading provider of aesthetic and dermatological solutions to practitioners worldwide. Since 1998, Cutera has been developing innovative, easy-to-use products that harness the power of science and nature to empower medical practitioners to provide safe and effective treatments for their patients. For more information, call +1 415-657-5500 or 1-888-4CUTERA or visit Cutera.com.

1,2 The data in the file. FDA clearance study. Cutera, Inc.

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Contacts

Media: EvolveMKD – Cutera@EvolveMKD.com
Investor Relations: Greg Parker, Vice President, FP&A – IR@Cutera.com

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